Effect of Early Eating on Body Composition

NCT04679155 | Unknown

• 1 other identifier: 117951
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks. There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days. The four studies that lasted 12 weeks in duration all have opportunities to improve upon, which will be discussed here. The first study performed by Gabel et al., focused primarily on measuring body weight, not body composition in older adults. The eating window also began later in the morning at 1000h and finished at 1800h. There also was no restriction on participants consuming caffeine during the fasting window. The second study conducted by Gasmi et al., was focused on strictly older male participants that were active and healthy, again, without measuring body composition. The third study conducted by Wilkinson et al., did not measure body composition and the eating window lasted 10 hours instead of 8. The fourth study performed by Chow et al., examined eTRE with adults aged 45+/-12 years old and did not mention any exclusion criteria based upon physical activity levels or restrictions on caffeine/artificial sweetener intake during the fasting window. Furthermore, none of the studies mentioned above examined eTRE against lTRE directly. We believe that the proposed study will address the concerns mentioned previously and further knowledge associated with eTRE.

Conditions

eTRE (Early Time Restricted Eating); lTRE (Late Time Restricted Eating)

Outcome Measures

Primary Outcomes (1)

• Body Composition

  fat mass vs. fat-free mass via BodPod

  <5 mins

Secondary Outcomes (3)

• upper body strength test

  <10 mins

• lower body strength test

  <10 mins

• health related quality of life questionnaire

  <10 mins

Study Arms (2)

eTRE

EXPERIMENTAL

participants allocated to this group will be required to eat only between 0800h and 1600h.

Behavioral: Eating Time Restriction

lTRE

ACTIVE COMPARATOR

participants allocated to this group will be required to eat only between 1200h and 2000h

Behavioral: Eating Time Restriction

Interventions

Eating Time Restriction BEHAVIORAL

early vs late time of day restriction

eTRE; lTRE

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• sedentary- lightly physically active (\<7,500 steps daily)
• BMI \> 25
• yo.

You may not qualify if:

• Have diabetes (self-reported)
• Have history of smoking (self-reported)
• Have history of cardiovascular disease (self-reported)
• Have BMI of \<24.9
• Are pregnant or become pregnant during the study (self-reported)
• Take medication for weight loss (self-reported)
• Physical activity level \> 7500 steps/day
• Unstable weight for 3 months prior to commencement of study (\>4kg weight loss/gain)
• Employed in a shift work position

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Exercise Nutrition Laboratory, Western University

London, Ontario, N6A3K7, Canada

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Central Study Contacts

Peter Lemon, PhD

CONTACT

519-661-2111; plemon@uwo.ca

Reed Zehr, MSc

CONTACT

519-661-2111; rzehr2@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)